Congress takes on meningitis; hearings set to begin Wednesday
Published: Tuesday, November 13, 2012 at 6:28 p.m.
Last Modified: Tuesday, November 13, 2012 at 6:28 p.m.
Two congressional oversight committees will hold hearings Wednesday and Thursday as part of an investigation into the fungal meningitis outbreak that has killed 32 patients and sickened more than 400 others.
Florida's three deaths were all in Marion County. The state has 23 fungal meningitis cases, most of them in Marion.
The Oversight and Investigations subcommittee of the House Energy and Commerce Committee is slated to hear testimony from Food and Drug Administration Commissioner Margaret Hamburg on Wednesday.
Ocala's U.S. Rep. Cliff Stearns chairs that subcommittee.
Congressional investigators last week also subpoenaed Barry Cadden, managing pharmacist of the now-closed New England Compounding Center in Massachusetts, which manufactured and supplied the tainted pain medication blamed for the outbreak.
On Thursday, the Senate Health, Education, Labor and Pensions Committee is scheduled to hear from Cadden, Massachusetts health officials, and experts from the U.S. Centers for Disease Control and Prevention.
Washington lawmakers want to know why NECC was allowed to continue operating after federal and state officials found problems at the Massachusetts facility.
Lawmakers also want to know whether regulators let known problems dating to 2003 continue unaddressed. Federal and state officials also had found evidence of environmental mold and fungus back in January at the NECC site, records show.
The committees are considering possible legislation that would shift oversight of compounding pharmacies from states to the FDA.
During October, new cases and deaths were announced almost daily. No new fungal meningitis cases have been identified in Florida since Oct. 30.
The illness is traced to three recalled lots of preservative-free methylprednisolone acetate (MPA). The last injection from the tainted lots of that medicine was administered on Sept. 26.
An estimated 14,000 patients nationwide might have received injections of the tainted medicine.
Florida Department of Health epidemiologist Dr. Carina Blackmore said the reporting trend resembles a curve: The numbers slowly grew, then peaked, then tapered off.
She warned there will be more cases identified in the future. Some additional patients almost certainly have been infected, but the incubation period for meningitis — which can last up to 150 or more days — has not yet run its course in all patients.
However, unlike the initial reported cases, the next wave will be small. She didn't predict a certain number.
"We really don't know what's going to happen," Blackmore said.
Unlike bacterial meningitis, fungal meningitis is not contagious. If it had been contagious the length of time for new cases to develop would have been longer and there would have been secondary groups of patients, Blackmore said.
What's feared now is that there will be new symptoms of the disease in patients, some of which are surfacing in a few other states. One such symptom is an abscess that forms around the fungal contamination and can be very difficult to treat, she said.
The new set of symptoms hasn't shown up in Florida patients yet, she said, but they might.
One patient who has filed a lawsuit is 62-year-old Marion County resident Vilinda York. She seeks more than $15,000 in damages from the pharmacy for pain and suffering.
Her attorney, John Piccin, filed the lawsuit last month in circuit court in Ocala. This week he added the Marion Pain Management Center in Ocala as a defendant. The clinic administered two injections to York, who has been in the hospital since Sept. 27.
Piccin said the Marion Pain Management Center had a responsibility to use only medicines that were safe and to warn patients of the risks of using medicines from NECC.
He also said that the steroid medicine NECC manufactured "was cheaper and of inferior quality" to the same medicines made by leading drug manufacturers.
Piccin said the pain management center knew the pharmacy was not overseen by the FDA and was supposed to have a prescription for each dose it manufactured. Instead, NECC produced as many as 17,000 vials of the steroid in bulk — a process that heightened the risk of contamination.
Piccin said the discovery process will reveal whether the Marion Pain Management Center first sent the NECC a prescription for York's medicine.
Attempts to contact Marion Pain Management Center were not successful. Three facilities in Marion County injected patients with the tainted medicine.
"(York) has had a rough course," Piccin said of his client. "Ms. York has been very ill."
Piccin said he now has 11 fungal meningitis clients and is talking to two more about representation.
Contact Fred Hiers at 867-4157 or firstname.lastname@example.org.
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